Mastodon

Pharmatex (Tablets, Capsules, Cream, Suppositories) Instructions for Use

ATC Code

G02BB (Intravaginal contraceptives)

Active Substance

Benzalkonium chloride (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vaginal contraceptive with spermicidal action

Pharmacotherapeutic Group

Other agents used in gynecology; contraceptives for topical use; intravaginal contraceptives

Pharmacological Action

Antiseptic with spermicidal action. It is a quaternary ammonium compound and belongs to cationic surfactants.

Spermicidal action is due to the ability of the active substance to destroy sperm membranes (first the flagella, then the heads), which makes it impossible for the egg to be fertilized by a damaged sperm.

The effect develops within 5-10 minutes after insertion into the vagina.

It does not affect the normal vaginal microflora or the menstrual cycle.

In vitro, Benzalkonium chloride is active against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus. It has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum. It is not active against Mycoplasma spp.

Pharmacokinetics

Benzalkonium chloride is not absorbed into the vaginal mucosa; it is removed by simple washing with water and with normal physiological secretions. When applied topically, it is practically not absorbed.

Indications

  • Local contraception.

ICD codes

ICD-10 code Indication
Z30.0 General advice and consultation on contraception
ICD-11 code Indication
QA21.1 Encounter for general counseling and advice on contraception

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer intravaginally 5-10 minutes before sexual intercourse; the exact time depends on the specific dosage form used.

Apply the cream, insert the capsule, or place the suppository deep into the vagina. Use a single dose before every act of sexual intercourse.

For the tablet form, insert one tablet intravaginally prior to each coital act, ensuring it is placed correctly for optimal effect.

Adverse Reactions

Possible adverse reactions include localized allergic responses and contact dermatitis. Patients may experience a burning sensation or itching in the vagina, and the partner may report similar symptoms on the penis.

Dysuria, or painful urination, can also occur. Discontinue use and consult a healthcare provider if any of these reactions are severe or persistent.

Contraindications

  • Hypersensitivity to benzalkonium chloride or any other component of the formulation.
  • Presence of vaginitis, vaginal ulcerations, or any other acute inflammatory conditions of the vaginal or cervical mucosa.
  • Irritation of the genital tract, as the product may exacerbate existing lesions or discomfort.

Use in Pregnancy and Lactation

Not used during pregnancy. It does not have a negative effect on the course of pregnancy. It is not excreted in breast milk and can be used during breastfeeding.

Special Precautions

The contraceptive effectiveness depends on the correct use of the drug containing Benzalkonium chloride.

In case of vaginal diseases, the use of benzalkonium chloride should be temporarily discontinued until the end of treatment with vaginal medications.

This method of contraception does not protect against sexually transmitted infections or those caused by HIV.

The use of soap for genital hygiene is prohibited 2 hours before and 2 hours after sexual intercourse, as soap destroys Benzalkonium chloride. Vaginal douching should be used 2 hours after sexual intercourse.

Drug Interactions

Concurrent intravaginal administration of other medications, such as creams or suppositories, can reduce the spermicidal effect of benzalkonium chloride.

Benzalkonium chloride is inactivated by soap and other anionic surfactants; avoid using soap for genital hygiene around the time of application.

Iodine-based solutions, including dilute preparations like 0.1% iodonate, chemically inactivate benzalkonium chloride upon contact.

Overdose

Overdose is unlikely due to the local route of administration and minimal systemic absorption. No specific antidote exists.

In case of accidental ingestion, symptomatic and supportive care is recommended. For local overexposure, such as intense irritation, discontinue use and rinse the affected area thoroughly with water.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Laboratoire Innotech International (France)

Manufactured By

Innothera Chouzy (France)

Or

Catalent France Beinheim, SA (France)

Packaging and Quality Control Release

INNOTHERA CHOUZY (France)

Dosage Form

Bottle OTC Icon Pharmatex Vaginal capsules 18.9 mg: 6 or 12 pcs.

Dosage Form, Packaging, and Composition

Vaginal capsules soft, translucent, light yellow, oval in shape; capsule content is an emulsion from white to white with a yellowish tint; slight stratification of the capsule content is possible.

1 caps.
Benzalkonium chloride 50% aqueous solution 37.8 mg,
   Equivalent to benzalkonium chloride content 18.9 mg

Excipients: dimethicone 1000, colloidal silicon dioxide (hydrophobic), hypromellose (hydroxypropylcellulose), PEG-7 glyceryl cocoate, macrogol 400, gelatin, glycerol.

6 pcs. – blisters (1) – cardboard packs.
6 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Laboratoire Innotech International (France)

Manufactured By

Laboratoires Chemineau (France)

Primary Packaging

LABORATOIRES CHEMINEAU (France)

Secondary Packaging

INNOTHERA CHOUZY (France)

Quality Control Release

INNOTHERA CHOUZY (France)

Dosage Form

Bottle OTC Icon Pharmatex Vaginal cream 1.2%: tube 72 g with dispenser

Dosage Form, Packaging, and Composition

Vaginal cream white, homogeneous, with a lavender scent.

100 g
Benzalkonium chloride 50% aqueous solution 2.4 g,
   Equivalent to benzalkonium chloride content 1.2 g

Excipients: anhydrous citric acid – 0.002 g, disodium hydrogen phosphate dodecahydrate – to pH 3.5-5.5, macrogol and ethylene glycol palmitostearate (Tefose® 63) – 24 g, lavender oil – 0.05 g, purified water – up to 100 g.

72 g – aluminum tubes (1) with a dispenser – cardboard packs.

Marketing Authorization Holder

Laboratoire Innotech International (France)

Manufactured By

Unither Liquid Manufacturing (France)

Packaging and Quality Control Release

INNOTHERA CHOUZY (France)

Dosage Form

Bottle OTC Icon Pharmatex Vaginal suppositories 18.9 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories white, cylindrical in shape with a conical end.

1 supp.
Benzalkonium chloride 50% aqueous solution 37.8 mg,
   Equivalent to benzalkonium chloride content 18.9 mg

Excipients: hypromellose – 9.1 mg, solid fat Witepsol S 51 – 1553.1 mg.

5 pcs. – blisters (1) – cardboard packs.
5 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Laboratoire Innotech International (France)

Manufactured By

Innothera Chouzy (France)

Dosage Form

Bottle OTC Icon Pharmatex Vaginal tablets 20 mg: 12 or 24 pcs.

Dosage Form, Packaging, and Composition

Vaginal tablets white, round, with a hole in the center.

1 tab.
Miristalkonium chloride 20 mg

Excipients: sodium bicarbonate – 111 mg, anhydrous citric acid – 96 mg, hydrated colloidal silicon dioxide – 12 mg, microcrystalline cellulose – 172 mg, magnesium stearate – 5.3 mg, lactose monohydrate – 363 mg, macrogol 6000 – 20.7 mg.

12 pcs. – polypropylene tubes (1) – cardboard packs.
12 pcs. – polypropylene tubes (2) – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS